The Patient Safety Journal. Medical Device Regulations and Patient Safety

Managing the risks to patient safety posed by medical devices is growing increasingly more complex and challenging. Healthcare professionals and the general public are largely unaware of the scope and limitations of existing medical device regulations. They often have inaccurate assumptions about medical device regulators’ capacities to safeguard the public health.

Compounding the problem is the common misapprehension that medical device regulations ensure both product safety and patient safety. Medical device regulations are directed at product safety only. Once a product has received regulatory approval, any subsequent uses of the product must be governed by patient safety principles, since patient safety is the ultimate goal. Additional measures beyond the satisfaction of medical device regulatory criteria are required for optimal outcomes. These measures are broadly related to medical device acquisition, use, maintenance, and surveillance.

This article examines the distinction between product safety and patient safety; the differences between regulating drugs and devices; and the additional measures that must be taken with medical devices to ensure that both product safety and patient safety are realized. The authors present a three-step holistic framework for promoting both product safety and patient safety. The three-step framework is applicable to the entire lifespan of a medical device. It does not depend on a particular medical device regulatory regime and is therefore universal in its application. Finally, the three-step framework is flexible and can be readily adapted by the users of medical devices.

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